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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Zynrelef (bupivacaine and meloxicam) Recalled for Defective Delivery Syringe

Agency Publication Date: August 12, 2022
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Summary

Heron Therapeutics, Inc. is recalling 1,790 kits of Zynrelef (bupivacaine and meloxicam), a prescription pain medication. The recall was initiated because one lot of the 400 mg/12 mg single-dose kits contains an incorrect 10 mL (12 mL) Luer slip syringe rather than the correct delivery system component. No incidents or injuries have been reported to date regarding this defect.

Risk

The inclusion of an incorrect syringe in the delivery kit may lead to difficulties in properly administering the medication or dosing errors during surgical use.

What You Should Do

  1. This recall affects Zynrelef (bupivacaine and meloxicam) 400 mg/12 mg single-dose application kits labeled with NDC 47426-301-02, specifically lot number 01126739 with an expiration date of 7/31/2023.
  2. Stop using the recalled product immediately and contact the manufacturer or your distributor to arrange for the return of the affected kits.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Zynrelef (bupivacaine and meloxicam) single dose application kit
Variants: 400 mg bupivacaine, 12 mg meloxicam
Lot Numbers:
01126739 (Exp 7/31/2023)
NDC:
47426-301-02

Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe was packaged in this kit lot.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90712
Status: Resolved
Manufacturer: HERON THERAPEUTICS, INC.
Sold By: pharmacies; healthcare providers
Manufactured In: United States
Units Affected: 1790 kits
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.